Predictability of OSA With a Subjective Screening Scale (OSASSS1)

NCT06092710 | Completed Results

• 1 other identifier: OSASSS1
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

the study aims to evaluate the accuracy correlation between subjective perception of the air flow through airways from patients and survey and/or polysomnography they spent, using a brief clinical protocol they answered with a manual therapist

Conditions

Obstructive Sleep Apnea; OSA

Keywords

obstructive sleep apnea; OSA; obstructive sleep apnea syndrome; sleep disorder; upper airways resistance syndrome UARS; subjective scale of air flow

Outcome Measures

Primary Outcomes (2)

• Test of Perception of Variations in the Passage of an Airflow Through the Rhino-oro-pharyngeal Passages According to the Categories of Items Used in the OSASSS Subjective Perception Scale

  In this study, we set out to create a scale of subjective perception of airflow. Assessment of subjects' perception of airflow using different positions or maneuvers: responses are scored for perceived ease of airflow. Items will be assigned "0" if they feel no expected change in airflow due to the maneuver up to "+1" if they feel a variation corresponding to the maneuver. Summed together, they define a score by item category (ST): * "constraining" (ST1: min= 0/Max= 4: dorsal decubitus "0/1", modified state of consciousness "0/1", cephalic flexion "0/1", tongue high to low position "0/1") * "facilitating" (ST2: min= 0/max=3: mandibular advancement "0/1", cephalic extension "0/1", nasal dilatation "0/1") to then assess whether the sensation of "facilitated or constrained" variation in the passage of air (ST1+ST2: min=0/max=7) is statistically significant for each group of participants compared to the absence of sensation of variation.

  during the clinical protocol, about 15 to 20 minutes

• Predictability of OSA Based on a Score Using Subjective Perception of Airway Collapsibility Between OSA and Control Subjects to Validate a Clinical Screening Tool

  In this study, we set out to create a scale, so we can only describe what we did. score by item category (ST): * ST1+ST2 (min=0/max=10) corresponds to the sensitivity of "facilitated or constrained" variation in the passage of air. * ST3: (min=0/max=3) corresponds to the practitioner's palpation of a synchronous contraction of the floor of the mouth (ventilatory defense sign) and sound turbulence on inspiration * ST4 (min=0/max=2) corresponds to lingual posture in supine position (aggravating if low) * ST5 (min=0/max=5) corresponds to patients' subjective perception of easy nasal ventilation, snoring, daytime ventilatory mode and nocturnal ventilatory mode * ST6 (min=0/max=3) corresponds to the teeth-skeletal class, tonsil grades and Mallampati stages * Epworth (min=0/max=2) corresponds to suspected sleep debt * FFF (min=0/max=1) corresponds to suspected fatigue SFI (min=0/max=13) corresponds to ST1+ST2+ST3 SFT (min=0/max=26) corresponds to SFI+ST4+ST5+ST6+Epworth+FFF

  during the examination and the OSASSS protocol (15 to 20 min)

Secondary Outcomes (1)

• Predictive Value on the Severity of OSA of the Subjective Upper Airway Collapsibility Perception Scale

  during the examination protocol, about 15 to 20 minutes

Study Arms (2)

study group with PSG and sleep survey

the study group will be recruited after their polysomnography but before its results, so patients and investigators will not have any data about Apnea Hypopnea Index (AHI) and sleep survey. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol

Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibility

control group with sleep survey

the control group will be recruited after a sleep survey with no sleep disorder. they will experiment their subjective perception of air flow through their airways with the guidance of a manual therapist during a 15 minutes protocol

Diagnostic Test: neuro-sensorial subjective evaluation of the airways collapsibility

Interventions

neuro-sensorial subjective evaluation of the airways collapsibility DIAGNOSTIC_TEST

verbal and manual guidance of subjects from a therapist to experiment the subjective perception of the air flow through their airways and airways collapsibility

Also known as: subjective perception scale of the air flow through airways, subjective perception of the air flow protocol, protocol of subjective perception of airways collapsibility, subjective perception scale of airways collapsibility

control group with sleep survey; study group with PSG and sleep survey

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with OSA objectified after polysomnography, sleepiness Epworth scale, fatigue Pichot scale, and subjects without OSA specified by negativation at sleepiness Epworth scale, fatigue Pichot scale, Berlin questionnaire

You may qualify if:

• Female or male subjects aged 18 to 77 years old
• subjects who have performed a PSG at the sleep medicine center André Renard for the study group
• subjects with no sleep disorder on sleep survey for the control group
• Subjects who agree to comply with the requirements of the study.
• Subjects who are of age (and know how to read and write) who have given their informed, explicit consent in advance to any procedure related to the trial, the study or the investigation conducted on human beings, with the objective of developing knowledge specific to the exercise of health care professions, as set out in Royal Decree No. 78 of 10 November 1967 on the practice of the health care professions (Act of 27 December 2005)

You may not qualify if:

• subjects with acute infections
• subjects with trauma within the last 72 hours
• subjects who already benefit from OSA treatment
• subjects with known perceptual disorders, for example post-stroke
• subjects with current or recent chemotherapy and radiotherapy treatment
• Pregnant women
• Criteria related to prior or concurrent treatments:
• Treatment with antipsychotics, anxiolytics, soporifics or muscle relaxants started within the two months preceding the study.
• Treatment with intraoral implants during the study or in the two months preceding the study

Sponsors & Collaborators

• Center for Sleep Medicine - Clinique André Renard: lead
• PIRON Alain, Osteopath - physiotherapist: collaborator
• LACROIX Alain, neurologist, MD, PhD: collaborator
• CHAKAR Bassam, neurologist, MD, PhD: collaborator

Study Sites (1)

Centre de médecine du sommeil- Clinique André Renard

Herstal, Liège, 4040, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Results Point of Contact

• Title: CEDRIC GARCION
• Organization: CAndreRenard

cedric.garcion.osteo@gmail.com

+33661817274

Study Officials

• Alain LACROIX, Neurologist, PhD

  Center of Sleep Medecine - Clinique André Renard

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2023
• Primary Completion: June 19, 2024
• Study Completion: November 30, 2024
• Last Updated: June 3, 2025
• Results First Posted: June 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: November 2023 to December 2024
• Access Criteria: Any approved researcher or reviewer who needs the data to compare, experiment or monitor the study for an official agency or international publication will be able to contact us and obtain the study data.

Locations

BE (1)